Noocholin Rompharm (Solution) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Noocholin Rompharm

Intravenous and intramuscular solution 250 mg/1 mL: 4 mL amp. 3 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless or light yellow in color.

Excipients: water for injections – up to 1 ml.

4 ml – ampoules made of colorless glass with a capacity of 5 ml (3) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Cholinomimetic. It is a precursor of acetylcholine. It acts primarily on cholinergic receptors in the CNS. Glycerophosphate, which is formed during the breakdown of choline alfoscerate, is a precursor of neuronal membrane phospholipids ( phosphatidylcholine).

It facilitates the transmission of nerve impulses in cholinergic neurons, improves the plasticity of neuronal membranes and receptor function.

Pharmacokinetics

After oral administration, approximately 88% of the choline alfoscerate dose is absorbed on average, with rapid distribution in organs and tissues.

It penetrates the BBB. It accumulates mainly in the brain (the concentration in the brain reaches 45% of that in plasma), lungs and liver.

85% is excreted by the lungs in the form of carbon dioxide, the remaining amount (15%) is excreted through the kidneys and through the intestines.

Indications

Cerebrovascular accidents of the ischemic type (acute and recovery period) and hemorrhagic type (recovery period); psychoorganic syndrome against the background of involutional and degenerative processes of the brain; consequences of cerebrovascular insufficiency or primary and secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased concentration; behavioral and affective disorders in old age – emotional lability, increased irritability, decreased interest; senile pseudomelancholia; multi-infarct dementia.

ICD codes

Dosage Regimen

Administer via intramuscular or intravenous routes. The dosage regimen is individualized based on the clinical condition and patient tolerance.

For acute cerebrovascular accidents (ischemic and hemorrhagic type in recovery phase), administer 1 gram (1000 mg) intravenously or intramuscularly once daily.

For chronic conditions (e.g., psychoorganic syndrome, cognitive impairments, multi-infarct dementia), the typical dose is 500 mg to 1000 mg intramuscularly or intravenously daily.

Prepare the intravenous injection by diluting the contents of one 4 mL ampoule (1 g) in 50 mL of a compatible infusion solution. Administer the IV infusion at a slow rate.

For intramuscular injection, administer the solution undiluted.

The treatment duration depends on the disease severity and therapeutic response. Courses may extend from several weeks to several months.

Reduce the dosage if adverse reactions, such as nausea, occur. This may be a sign of dopaminergic activation.

Do not use in patients with hypersensitivity to choline alfoscerate. This product is contraindicated during pregnancy, lactation, and in patients under 18 years of age.

Adverse Reactions

From the digestive system: nausea, abdominal pain.

From the nervous system: short-term confusion.

Contraindications

Hypersensitivity to choline alfoscerate; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Nausea may be a consequence of dopaminergic activation. If nausea occurs, the dose of choline alfoscerate should be reduced.

Effect on the ability to drive vehicles and machinery

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.